FDA Advisers Back Maternal RSV Vaccine as Pfizer Says Safety Concerns Can Be Studied Post-Approval

Contact Your Elected Officials
The Epoch Times Header

Advisers to the U.S. Food and Drug Administration (FDA) voiced support on May 18 for Pfizerโ€™s maternal RSV vaccine even after several expressed concerns over premature births.

Outside experts on the Vaccines and Related Biological Products Advisory Committee unanimously said data from two trials run by Pfizer were sufficient to support the vaccine being effective at preventing RSV disease in infants. They also voted 10โ€“4 in the affirmative when asked if the data from the trials were sufficient to demonstrate the safety of the vaccine.

The votes set up FDA clearance for what would be the first maternal vaccine for the respiratory syncytial virus, or RSV.

Pfizerโ€™s vaccine, a recombinant protein subunit shot, targets the RSV A and RSV B subgroups in a 120 microgram dose that would be given to pregnant women in the second or third trimester. The goal would be to relay antibodies against RSV to fetuses, conferring protection that is supposed to last through the first year of life.

The vaccine was 81.8 percent efficacious through 90 days after birth against severe lower respiratory tract illness due to RSV. The efficacy dropped to 69.4 percent after another 90 days.

For any RSV-positive medically attended lower respiratory tract illness, the vaccine started at 57.1 percent efficacy and dropped to 51.3 percent over the same timeframe, according to data from a phase 3 trial that included about 3,500 vaccinated pregnant women.

The efficacy for medically attended lower respiratory tract illness from any cause was just 2.5 percent at 180 days and 5.1 percent at 360 days.

FDA staffers said in a briefing document that the trial showed โ€œsuccessful vaccine efficacy, and the advisers seconded that view with their unanimous vote.

But multiple experts expressed concerns about the risk of the vaccine causing premature births, a risk found in a similar product made by GlaxoSmithKline that prompted the company to halt testing in 2022.

In Pfizerโ€™s trial, there were more premature deliveries in the vaccinated arm than the placebo armโ€”5.7 percent in the former versus 4.7 percent in the latter.

โ€œThat is hanging over this program,โ€ Dr. Paul Offit, one of the FDAโ€™s advisers, said during Thursdayโ€™s meeting.

By Zachary Stieber

Read Full Article on TheEpochTimes.com

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

On the Major Leagueโ€™s periphery: A major trip through the minors

For Nick Dunn, the trek through the minors is a trifecta of physical, mental, and organizational hurdles filled with politics, roster volatility, and injuries.

Peace In Ukraine Wonโ€™t End The Westโ€™s Hybrid War On Russia

The Westโ€™s Hybrid War on Russia to follow peace in Ukraine is inevitable due to neoconservatives and liberal-globalists in its decision-making ecosystem.

Was Texas Storm Manmade?

Another โ€œ1-in-100 yearsโ€ weather event in Kerr County happened next to a Texas designated โ€œWeather Modification Map of Rain-Enhancement Projects in Texasโ€.

The America Party Will Harm Democrats The Most

Elon Musk formed the America Party after an X poll asking his followers if they wanted โ€œindependence from the two-party system!

Democrats Exhibit the Dunning-Kruger Effect (DKE)

โ€œThe Dunning-Kruger effect is a cognitive bias where people with low ability at a task overestimate their competence, while those with high ability underestimate their competence.

Doctor Groups Sue RFK Jr. Over Altered COVID-19 Vaccine Recommendations

Health Sec. RFK, Jr.โ€™s decision to remove recommendations that healthy children and pregnant women receive COVID-19 vaccines was illegal, lawsuit alleges.

Los Angeles Mayor Confronts Federal Immigration Officers at MacArthur Park

After decrying federal immigration enforcement operations in Los Angeles, Mayor Karen Bass confronted ICE officers as they gathered at a city park.

What We Know About Victims of Texas Floods

The death toll from a series of devastating Texas floods over the July 4 weekend has risen to more than 100 people, many of whom are children.

Trial Begins Over Trump Adminโ€™s Deportations of Pro-Palestinian Students

A trial over President Trumpโ€™s attempts to deport pro-Palestinian activists began on July 7 with attorneys debating free speech.

Trump Says BRICS Members Will Get Additional 10 Percent Tariffs Over Dedollarization Attempt

Trump warns BRICS he's imposing additional 10% tariff on nations, as bloc was created to replace U.S. dollar as dominant currency for international trade.

Top Trump Officials to Hold Trade Talks With China in August

The Trump administrationโ€™s top trade negotiators are set to meet with Chinese officials in early August, Commerce Secretary Howard Lutnick said.

Trump, Netanyahu Meet for 2nd Consecutive Day at White House to Discuss Gaza

U.S. President Donald Trump is hosting Israeli Prime Minister Benjamin Netanyahu at the White House on July 8 for a second consecutive day.

Trump Extends Federal Hiring Freeze Until October

Trump issued memo extending federal hiring freeze until Oct. 15, maintaining exemptions for positions related to the armed forces and public safety.
spot_img

Related Articles